21 C.F.R. § 524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension.
Title 21 - Food and Drugs
(a) Specifications. Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 days. (2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci). [66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension.
